Dentofacial DeformitiesOCHIRONCT06494709
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking
A study testing photographs in people with Dentofacial Deformities and Orthognathic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dentofacial Deformities, Orthognathic Surgery, Social Perception
- What is being tested?
- photographs
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Naïve subject with regard to dentofacial deformities and their management
- Subject with no known facial pathology
- Subject having provided an informed consent
- Subject > 18 years old
Who cannot join
- Subject familiar with dentofacial deformities and their management (e.g., health professionals in the relevant specialties)
- Subject with known facial pathology (dentofacial deformity or other)
- Subject under guardianship, curators or justice protection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, Picardie, 80054
Stéphanie DAKPE, MD, 0033 3 22 66 83 25, dakpe.stephanie@chu-amiens.fr
Sylvie TESTELIN, Pr
About this study
Official title: Pilot Study of Quantitative Evaluation of Attention to Faces of Patients With Orthognathic Surgery Using Eye-tracking
Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. If these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. Angle's classification defines three classes of dental occlusion: class I, when the ratio between the maxillary and mandibular first molars is normal, class II when the upper molar is too far forward, and class III when it is too far back. Class II and III dysmorphoses can result in an alteration of the masticatory function, pain (TMJ, headaches) or sleep apnea. At the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. Class II and II usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. This surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life.
Standardized photographs presenting control subjects (class I) and patients (class II and class III) before and after surgery will be included in an approximately 10 min video sequence. Naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. The total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.
- Being tested
- photographs
- Keywords
- Dentofacial Deformities, orthognathic surgery, social perception, eye tracking
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photographsOther
Standardized photographs presenting 10 control subjects (class I) and patients with dentofacial deformities (10 class II and 10 class III) before and after surgery - from the front and from the side - will be used to form an approximately 10 min video sequence using the Tobii Pro Lab® software (Tobii Pro AB, Danderyd, Sweden). The naive participants will look at the percept during which the faces of the controls and the patients will alternate, with the only instruction being free visual exploration of the percept.
The fixation duration in the defined areas of interest (eyes, nose, mouth, chin) will be recorded with a Tobii® Pro X3-120 eye-tracking device and the results will be processed with the Tobii Pro Lab® software.
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fixation duration in the "lower third of the face (mouth/chin)" area of interest
Total fixation duration in the "lower third of the face (mouth/chin)" area of interest, measured in seconds with eye-tracking technique
Measured: one day
Secondary outcomes (5)
Total fixation duration in the "eyes" area of interest
Total fixation duration in the "eyes" area of interest, measured in seconds with eye-tracking technique
Measured: one day
Total fixation duration in the "nose"" area of interest
Total fixation duration in the "nose" area of interest, measured in seconds with eye-tracking technique
Measured: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients before orthognathic surgery compared to control subjects.
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients before orthognathic surgery compared to control subjects.
measured in seconds with eye-tracking technique
Measured: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients after orthognathic surgery compared to control subjects.
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients after orthognathic surgery compared to control subjects.
measured in seconds with eye-tracking technique
Measured: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in class II patients before orthognathic surgery compared to class III patients.
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in in class II patients before orthognathic surgery compared to class III patients.
measured in seconds with eye-tracking technique
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start2 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Faire Faces
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494709
- Sponsor's protocol ID
- PI2022_843_0146
- Acronym
- OCHIRO
- Status last verified
- Sep 2026
- First submitted
- 2 Jul 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Quantitative Evaluation of Attention to Faces of Patients With Orthognathic Surgery Using Eye-tracking
- ClinicalTrials.gov ID
- NCT06494709
- Acronym / sponsor ID
- OCHIRO / PI2022_843_0146
- Keywords
- Dentofacial Deformities, orthognathic surgery, social perception, eye tracking
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Institut Faire Faces
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. If these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. Angle's classification defines three classes of dental occlusion: class I, when the ratio between the maxillary and mandibular first molars is normal, class II when the upper molar is too far forward, and class III when it is too far back. Class II and III dysmorphoses can result in an alteration of the masticatory function, pain (TMJ, headaches) or sleep apnea. At the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. Class II and II usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. This surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life.
Standardized photographs presenting control subjects (class I) and patients (class II and class III) before and after surgery will be included in an approximately 10 min video sequence. Naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. The total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Naïve subject with regard to dentofacial deformities and their management
- Subject with no known facial pathology
- Subject having provided an informed consent
- Subject > 18 years old
Key exclusion criteria (3 listed)
- Subject familiar with dentofacial deformities and their management (e.g., health professionals in the relevant specialties)
- Subject with known facial pathology (dentofacial deformity or other)
- Subject under guardianship, curators or justice protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photographsStandardized photographs presenting 10 control subjects (class I) and patients with dentofacial deformities (10 class II and 10 class III) before and after surgery - from the front and from the side - will be used to form an approximately 10 min video sequence using the Tobii Pro Lab® software (Tobii Pro AB, Danderyd, Sweden). The naive participants will look at the percept during which the faces of the controls and the patients will alternate, with the only instruction being free visual exploration of the percept. The fixation duration in the defined areas of interest (eyes, nose, mouth, chin) will be recorded with a Tobii® Pro X3-120 eye-tracking device and the results will be processed with the Tobii Pro Lab® software. | Other | – |
Primary outcome
Total fixation duration in the "lower third of the face (mouth/chin)" area of interest
Time frame: one day
Total fixation duration in the "lower third of the face (mouth/chin)" area of interest, measured in seconds with eye-tracking technique
5 secondary outcomes
Total fixation duration in the "eyes" area of interest
Time frame: one day
Total fixation duration in the "nose"" area of interest
Time frame: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients before orthognathic surgery compared to control subjects.
Time frame: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in patients after orthognathic surgery compared to control subjects.
Time frame: one day
Total fixation duration in the eyes", the "nose" and the "lower third of the face (mouth/chin)" areas of interest in class II patients before orthognathic surgery compared to class III patients.
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing photographs in people with Dentofacial Deformities and Orthognathic Surgery, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Dakpe, Pr (03 22 08 90 80, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fixation duration in the "lower third of the face (mouth/chin)" area of interest (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.